Project Breast47: Effect of an Educational Intervention

NCT05267171 | Completed Results DMC

• 1 other identifier: 2021.341
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most frequently diagnosed malignant tumor in women. In 2018, in Spain, the estimated incidence was 101/100,000 women. Screening strategies and greater knowledge of risk factors by the population have contributed to a better prognosis. Specifically, in the case of behavioral factors, making women aware of their influence enables them to establish preventive measures themselves. Technologies are becoming a channel of communication, from a healthcare perspective, between the population and healthcare personnel. There are even specific terms like eHealth or mHealth. There is beginning to be evidence that collects the benefits and ways of using web-apps to achieve modification of risky behaviors and/or behaviors to prevent pathologies are acquired. The use of digital media, such as a web-app, to publicize BC risk factors makes it possible to specifically establish measures aimed at reducing its prevalence, which in turn will contribute to reducing the number of cases of BC. CM. On the other hand, making women aware of their BC risk factors, as well as quantifying the risk of developing the tumor, is useful for them to become aware of the magnitude of the problem and adopt measures to minimize their risk. Since there is no digital strategy in Asturias that informs and reduces the risk of developing breast cancer, through the modification of the main risk factors, in young women, the present study has been proposed with the aim of evaluating the effectiveness and feasibility of an educational intervention for BC risk prevention through the use of a Web-App in women residing in health area VII of the Principality of Asturias.

Conditions

Breast Neoplasm; Primary Prevention; Risk Factors; Telemedicine

Outcome Measures

Primary Outcomes (11)

• Behavioral BC Risk With an Educational Intervention for Prevention

  The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire. The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation). Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations).

  Baseline

• Feasibility of an Educational Intervention for BC Risk Prevention Through the Use of a Web-App

  PostIntervention - Feasibility will be measured with satisfaction questionnaire. Satisfaction related to the web-app used in the intervention was measured with the SUS scale in its validated version in Spanish. This is a standardized scale that allows measuring the perception of the usability and satisfaction of a system. It consists of 10 items that are scored on a Likert-type scale ranging from 1, which is totally disagree, to 5, which is totally agree. After calculating the result, we will obtain a score in a range from 0 to 100, where its average is 68. Above this figure and up to 84, it is considered "good usability." Equal to or greater than 85 is considered "excellent usability". This part was only evaluated in those women belonging to the intervention group and who, therefore, had been able to use the web-app.

  12 weeks (end of intervention)

• Knowledge of BC Risk With an Educational Intervention for Prevention

  Knowledge of risk factors and signs of BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 9 are related to knowledge of risk factors and 9 to signs and symptoms. The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge.

  Baseline

• Barriers to Prevent BC With an Educational Intervention for Prevention

  Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers).

  Baseline

• BC Risk Perception With an Educational Intervention for Prevention

  Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception).

  Baseline

• Breast Self-examination With an Educational Intervention for Prevention

  Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: "Do you perform breast self-examination once a month?" with a dichotomous yes/no response option.

  Baseline

• Knowledge of BC Risk With an Educational Intervention for Prevention

  Post Intervention - Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception).

  12 weeks (end of intervention)

• Behavioral BC Risk With an Educational Intervention for Prevention

  PostIntervention - The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire. The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation). Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations).

  12 weeks (end of intervention)

• Knowledge for BC Risk With an Educational Intervention for Prevention

  PostIntervention - Knowledge of risk factors and signs of BC with the MARA questionnaire (4 subscales and 31 items of which 9 are related to knowledge of risk factors and 9 to signs and symptoms) The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge.

  12 weeks (end of intervention)

• Barriers to Prevent BC With an Educational Intervention for Prevention

  PostIntervention - Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers).

  12 weeks (end of intervention)

• Breast Self-examination With an Educational Intervention for Prevention

  PostIntervention - Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: "Do you perform breast self-examination once a month?" with a dichotomous yes/no response option.

  12 weeks (end of intervention)

Study Arms (2)

Intervention group

EXPERIMENTAL

Other: Web access

Control group

NO INTERVENTION

Interventions

Web access OTHER

The intervention group will have access to the website where the information is provided. The control group will not have this access.

Intervention group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who agree to participate with no previous diagnosis of breast cancer

You may not qualify if:

• Women who do not have adequate physical or psychological characteristics to participate in the study
• Women who do not have the means to regularly access the web-app that will be used to develop the educational intervention
• Women who cannot be contacted by email

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

Universidad de Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

Related Publications (1)

• Martin-Payo R, Leiros-Diaz C, Urena-Lorenzo A, Cachero-Rodriguez J, Fernandez-Arce L, Fernandez-Alvarez MDM. A web-based intervention to promote healthy lifestyles in women under 45 years: a randomized controlled trial (RCT) for breast cancer prevention. Mhealth. 2025 Oct 28;11:54. doi: 10.21037/mhealth-25-2. eCollection 2025.

  PMID: 41211018 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Claudia Leirós Díaz
• Organization: Universidad de Oviedo

claudia_leiros@hotmail.com

663571819

Study Officials

• Claudia Leirós

  Universidad de Oviedo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN; MSC

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 4, 2022
• Study Start: January 15, 2022
• Primary Completion: April 4, 2022
• Study Completion: June 26, 2022
• Last Updated: October 29, 2024
• Results First Posted: October 29, 2024

Record last verified: 2024-10

Locations

ES (1)